Nerve ConductionNCT01022437
Geranium Oil and Its Components for the Relief of Numbness-OB 100
A study testing Geranium Oil with component PN-34 in people with Nerve Conduction and Numbness, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Conduction, Numbness
- What is being tested?
- Geranium Oil with component PN-34
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Neuropathy with the inability to feel touch in a standard nylon filament test
- Signed informed consent
Who cannot join
- Pregnant or nursing
- Known allergies to geranium oil or geranium oil fractions
- Open sore in the area of numbness
- Migraine headaches or headaches to strong smells
Trial locations and contacts
1 site in 1 country.
United States1 site
Penningto Biomedical Research Center
Baton Rouge, Louisiana, 70809
About this study
This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.
Read the detailed description
This is a pilot study to define the time course, the incidence of sensation restoration and the improvement in nerve conduction in people with numbness by using topical geranium oil.
- Conditions
- Nerve Conduction, Numbness
- Being tested
- Geranium Oil with component PN-34
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geranium Oil with component PN-34Other
Geranium oil as a topical application to the body that is numb, time to determine how long it takes for the feeling to return, if it does so, and if the return of feeling is maintained by daily topical application of oil over 12 weeks. This including the process of absorption, distribution and localization.
| Study group | Role | What they receive |
|---|---|---|
| Geranium Oil and component PN-34 | Experimental | Not described Receives: Other: Geranium Oil with component PN-34 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to numbness relief and restoration of sensation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve ConductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Alok Gupta, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022437
- Sponsor's protocol ID
- PBRC 28041
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2009
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geranium Oil and Its Components for the Relief of Numbness-OB 100
- ClinicalTrials.gov ID
- NCT01022437
- Acronym / sponsor ID
- PBRC 28041
- Conditions
- Nerve Conduction, Numbness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.
Detailed description
This is a pilot study to define the time course, the incidence of sensation restoration and the improvement in nerve conduction in people with numbness by using topical geranium oil.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geranium Oil and component PN-34 | Experimental | Other: Geranium Oil with component PN-34 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Neuropathy with the inability to feel touch in a standard nylon filament test
- Signed informed consent
Key exclusion criteria (4 listed)
- Pregnant or nursing
- Known allergies to geranium oil or geranium oil fractions
- Open sore in the area of numbness
- Migraine headaches or headaches to strong smells
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geranium Oil with component PN-34Geranium oil as a topical application to the body that is numb, time to determine how long it takes for the feeling to return, if it does so, and if the return of feeling is maintained by daily topical application of oil over 12 weeks. This including the process of absorption, distribution and localization. | Other | Geranium Oil and component PN-34 |
Primary outcome
Response to numbness relief and restoration of sensation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alok Gupta, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geranium Oil with component PN-34 in people with Nerve Conduction and Numbness, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to numbness relief and restoration of sensation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.